Cleared Traditional

PLANMED SOPHIE NUANCE CLASSIC

K042671 · Planmed OY · Radiology

Nov 2004

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K042671 is an FDA 510(k) clearance for the PLANMED SOPHIE NUANCE CLASSIC, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Planmed OY (Roselle, US). The FDA issued a Cleared decision on November 19, 2004, 51 days after receiving the submission on September 29, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number	K042671 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2004
Decision Date	November 19, 2004
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF